EUCTR2010-023648-34-PL进行中（未招募）不适用
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer – Cachexia (NSCLC-C): A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients with NSCLC-C
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 477
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Females and males at least 18 years of age
- •Documented histologic or cytologic diagnosis of AJCC Stage III or IV NSCLC. Stage III patients must have unresectable disease.
- •With regard to chemotherapy and/or radiation therapy: Patients may be receiving maintenance chemotherapy; Patients planning to initiate a new chemotherapy and/or radiation therapy regimen may do so only within ± 14 days of randomization; Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization. At least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization.
- •Involuntary weight loss of greater than/equal to 5% body weight within 6 months prior to screening or a screening BMI <20 kg/m2.
- •Body mass index less than/equal to 30 kg/m2
- •ECOG less than/equal to 2
- •Estimated life expectancy of >4 months at the time
- •of screening
- •Adequate hepatic function, defined as aspartate
- •aminotransferase (AST) and alanine
- •aminotransferase (ALT) levels =5 xupper limit of
- •normal (ULN)
- •Adequate renal function, defined as creatinine
- •=2 xULN, or calculated creatinine clearance
- •>30 ml/minute
- •The patient is able to understand and comply with
- •the procedures for the HGS evaluation.
- •If the patient is a woman of childbearing potential or
- •a fertile man, he/she must agree to use an effective
- •form of contraception during the study and for
- •30 days following the last dose of study drug (an
- •effective form of contraception is abstinence, a
- •hormonal contraceptive, or a double-barrier method).
- •The patient must be willing and able to give signed
- •informed consent and, in the opinion of the
- •Investigator, to comply with the protocol tests and
- •procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 317
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •Other forms of lung cancer (eg, small cell, mesothelioma)
- •Women who are pregnant or breast-feeding
- •Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Patients must be well recovered from acute effects of surgery prior to screening. Patients should not have plans to undergo major surgical procedures during the treatment period.
- •Currently taking prescription medications intended
- •to increase appetite or treat weight loss; these
- •include, but are not limited to, testosterone,
- •androgenic compounds, megestrol acetate,
- •methylphenidate, and dronabinol
- •Patients unable to readily swallow oral tablets. Patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded
- •Has an active, uncontrolled infection
- •Has uncontrolled diabetes mellitus
- •Has untreated clinically relevant hypothyroidism
- •Has known or symptomatic brain metastases
- •Patients receiving strong CYP3A4 inhibitors within
- •14 days of randomization (see Appendix VI)
- •Patients receiving tube feedings or parenteral
- •nutrition (either total or partial). Patients must have
- •discontinued these treatments for at least 6 weeks
- •prior to Day 1, and throughout the study duration.
- •Other clinical diagnosis, ongoing or intercurrent
- •illness that in the Investigator’s opinion would
- •prevent the patient’s participation
- •Has had previous exposure to Anamorelin HCl
- •Patients actively receiving a concurrent
- •investigational agent
研究者
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